Phase II Study of Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndrome
The Study Drugs:
Gemtuzumab ozogamicin is designed to attach to CD33, a certain protein that is often found
in leukemia cells, causing them to die.
Decitabine is designed to damage the DNA (the genetic material) of cells, which may cause
cancer cells to die.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive decitabine
through a needle in your vein over 1 and 1/2 hours on Days 1-5 of each cycle. You will also
receive gemtuzumab ozogamicin by vein over about 1 hour after you receive decitabine on Day
5 of each 4-8 week cycle.
During Cycle 1 only, if a bone marrow test done 2 weeks after you receive your first study
drug treatment shows abnormal leukemia cells, you will receive another treatment with
decitabine by vein over 1 and 1/2 hours for 5 days.
Gemtuzumab may cause allergic reactions, nausea, and vomiting. To help decrease the risk of
such side effects, you will receive Benadryl (diphenhydramine), acetaminophen, meperidine,
and hydrocortisone. You may receive these drugs by vein, or by mouth on each of the days
you get gemtuzumab ozogamicin.
At every study visit, you will be asked if you have experienced side effects and to list any
drugs you may be taking.
During Cycle 1, blood (about 2 teaspoons) will be drawn at least 1 time each week for
routine tests. If the doctor thinks it is necessary, you may be asked to have additional
On Day 1 of every cycle, your performance status will be recorded and your vital signs will
On Days 1-5 of Cycle 1, your vital signs will be measured.
Between Days 12 and 16 of Cycle 1, you will have a bone marrow aspirate if you have a
diagnosis of AML or high-risk MDS to check the status of the disease. This test may be
delayed if your doctor does not think you are in remission.
During Cycles 2-3, blood (about 2 teaspoons) will be drawn for routine tests at least 2
times each month.
On Day 1 of Cycles 2 and beyond, you will have a physical exam, including measurement of
your vital signs.
During Cycles 4 and beyond, blood (about 2 teaspoons) will be drawn for routine tests at
least 1 time each month.
If the doctor thinks it is necessary, you will have a bone marrow aspirate every 1-3 months
to check the status of the disease.
You should tell the study doctor about all drugs and supplements you are taking while you
are on this study.
Length of Study:
You may receive the combination of decitabine and gemtuzumab ozogamicin for up to 6 cycles.
After this, if your doctor thinks it is in your best interest, you may continue to receive
decitabine alone for up to 24 cycles. During this part of study, your performance status
will be recorded, you will have a physical exam, and your vital signs will be measured on
Day 1 of each cycle. Blood (about 2 teaspoons) will be drawn for tests once a month. You
will be taken off study early if the disease gets worse, you experience intolerable side
effects, or your doctor thinks that it is no longer in your best interest to receive the
Once you are off study, you will have follow-up visits every month for up to 2 years. At
these visits, blood (about 2 teaspoons) will be drawn for routine tests.
This is an investigational study. Gemtuzumab ozogamicin is FDA approved and commercially
available for the treatment of AML that has come back after treatment in patients over the
age of 65 years. Decitabine is FDA approved and commercially available for the treatment of
MDS. The use of gemtuzumab ozogamicin and decitabine in combination is investigational.
Up to 100 participants will take part in this study. All will be enrolled at MD Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients with Complete Remission
Twice a month blood tests during Cycle 1 (one a month following), bone aspirate between days 18 to 24; up to 24 (4-6 week) cycles
Gautam Borthakur, M.D.
M.D. Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|